AneuFix - Prophylactic Sac Filling

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307992
• Other study ID #: Triplemed 003
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: TripleMed B.V.
• Contact: Florie Daniels
• Phone: +31 6 38 19 92 91
• Email: f.daniels[@]triple-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.

Description:

The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries.

ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:

• Open IMA AND

• 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) >17,5cm2 OR

• 2 patent lumbars AND a CSAIMA >15cm2 OR

• 3 patent lumbars AND a CSAIMA >12,5 cm2 OR

• 4 patent lumbars AND a CSAIMA >10 cm2 OR

• 5 patent lumbars AND a CSAIMA >7,5 cm2

• Infrarenal neck according to the IFU of the EVAR device

• Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used

• Patient having a life expectation of at least 2 years

• Being older than 18 years

• Willing and able to comply with the requirements of this clinical study

Exclusion Criteria:

• Patient not able or willing to give written Informed Consent

• Patient undergoing emergency procedures

• Patient undergoing EVAR for ruptured or symptomatic AAA,

• Patient with a suprarenal AAA

• Patient with an inflammatory AAA (more than minimal wall thickening)

• Patient with an infrarenal neck unsuitable for endovascular fixation (including so called "hostile necks") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used

• Patient in which a bilateral retroperitoneal incision is required for EVAR

• Patient in which a sacrifice of both hypogastric arteries is required

• Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation

• Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent

• Patient with active infection present

• Patients scheduled for or having received an organ transplant

• Patient with limited life expectation due to other illness (<1 year)

• Patient with non-iatrogenic bleeding diathesis

• Patient with connective tissue disease

• Women of child-bearing potential

• Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endoleak

Intervention

Device:
• Prophylactic sac filling with AneuFix
ANEUFIX is administered by injection into the AAA via transferal access at the time of EVAR placement using imaging techniques to guide the place of injection.

Locations

Country	Name	City	State
Netherlands	VUmc	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
TripleMed B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success	Technical Success as demonstrated by the feasibility to fill the AAA sac after EVAR during the same procedure, and by the rate of (all) endoleaks after EVAR followed by the AneuFix procedure	24 hours
Primary	Clinical Success rate	Clinical Success as demonstrated by the occurrence of type II endoleaks at 6 months after EVAR, and aneurysmal sac growth at 6 months after EVAR	6 months
Primary	Clinical Success rate	Clinical Success as demonstrated by the occurrence of type II endoleaks at 12 months after EVAR, and aneurysmal sac growth at 12 months after EVAR	12 months
Secondary	Intraoperative occurrence of complications	Adverse events occurring during the surgical intervention are registered.	24 hours
Secondary	Peri-operative complications	Rate of peri-operative complications	30 days
Secondary	Prevention of (any type of) endoleak	Occurrence of (any type of) endoleak	1, 6 and 12 months
Secondary	adverse events	Occurrence of adverse events and adverse device effects	1, 6 and 12 months
Secondary	Re-interventions	Rate of secondary endovascular or surgical re-interventions	1, 6 and 12 months
Secondary	Aneurysm rupture	Rate of aneurysm rupture	6 and 12 months
Secondary	Proportion of patients surviving 24 months after treatment	Survival throughout the study up until 24 months	24 months